Source: Teva Pharmaceutical Industries Ltd.

Jerusalem, Israel and Lund, Sweden, June 25, 2009 – Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced completion of patient enrollment for the second pivotal Phase III clinical trial, BRAVO, evaluating the novel, oral once-daily immunomodulating compound, laquinimod, for the treatment of relapsing-remitting multiple sclerosis (RRMS). BRAVO is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex®.

The BRAVO study completed patient enrollment in June, recruiting more than 1,200 patients at 156 sites in the United States, Europe, Israel and South Africa.

“Teva and Active Biotech are encouraged by the potential of laquinimod to address patients’ unmet need for an oral immunomodulating MS therapy that provides efficacy while maintaining safety” said Moshe Manor, Teva’s Group Vice President, Global Branded Products. “We look forward to continuing our clinical Phase III program of laquinimod, and hope it will offer enhanced quality of health for RRMS patients”.

ALLEGRO, the first global Phase III trial of laquinimod, completed enrollment in November 2008, after recruiting more than 1,000 patients at 152 sites in North America, Europe and Asia. The trial is currently ongoing.

In February 2009, laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA).

For more information, please visit www.tevapharm.com

This entry was posted on Tuesday, June 30th, 2009 at 8:27 am and is filed under All Articles, Clinical Trials. You can follow any responses to this entry through the RSS 2.0 feed.